Petroleum Skin Protectant

Product NDC
55319-069
11-digit product format
553190069
Labeler code
55319
Product ID
55319-069_4b9301f0-bf20-4b2e-e063-6394a90ab0da
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
Family Dollar Stores, Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-01-05
Substance
PETROLATUM
Active strength
1 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55319-06955319-069-27DDiscontinued by firm2026-10-27

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Petroleum Skin Protectant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204754Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac7da793-8a39-4b47-b075-a4c4820cadadAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-069-27Petroleum Skin Protectant368 g in 1 JARJELLY36818
55319-069-96Petroleum Skin Protectant213 g in 1 JARJELLY21318

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UPETROLEUM SKIN PROTECTANT (WHITE PETROLATUM) JELLY [FAMILY DOLLAR SERVICES, INC]2
PETROLATUMACTIVE MOIETY4T6H12BN9UPETROLEUM SKIN PROTECTANT (WHITE PETROLATUM) JELLY [FAMILY DOLLAR SERVICES, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-069PETROLEUM SKIN PROTECTANT (WHITE PETROLATUM) JELLY [FAMILY DOLLAR STORES, INC]17Current NDC, Legacy NDC, 2 package rows20250305_ac7da793-8a39-4b47-b075-a4c4820cadad.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 65 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.0bc6812a-5c2a-7bb9-e063-6294a90a36e32023-12-05WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.34fae56e-367d-4659-af2d-1c9ddaf1639c2023-12-05WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDERejoice International Corp.0ba98cdf-489e-dc2a-e063-6294a90adb382023-12-04WarningsExact identifier
application number: M016
Diaper Rash Cream 2.5ozZINC OXIDEChina Ningbo Shangge Cosmetics Technology Corp.0baa8a14-8655-d77c-e063-6294a90ab8aa2023-12-04WarningsExact identifier
application number: M016
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC86472a3d-7138-4141-8422-ab20c17a46e02023-12-04WarningsExact identifier
application number: M016
SOOTHE Moisturizing Rescue CreamOATMEALRodan & Fields91163267-c2aa-47b3-b290-d1605536d8062023-12-04WarningsExact identifier
application number: M016
Manzatin-E Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.cafd084f-8493-4d6e-b256-2d4b4282f8662023-12-01WarningsExact identifier
application number: M016
Manzatin Diaper Rash Skin ProtectantZINC OXIDELaboratorios Zepol S.A.5c1618a4-ca08-4814-a556-74e79db618b92023-12-01WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMNEW PRIDE CORPf6634410-fa1f-7987-e053-2995a90abb062023-12-01WarningsExact identifier
application number: M016
Cetaphil Cracked Skin Repair BalmDIMETHICONEGalderma Laboratories, L.P.5efb3ef0-6ee9-4ef8-b81e-90bd1825c9562023-11-30WarningsExact identifier
application number: M016
Cetaphil Cracked Skin RepairDIMETHICONEGalderma Laboratories, L.P.27d74e0f-8359-4c59-bf7f-acade7f4545c2023-11-30WarningsExact identifier
application number: M016
Sheffield Advanced Scar GelADVANCED SCAR GELSheffield Pharmaceuticals LLCab78b946-81ed-442c-a167-26c26c7fe8a12023-11-30WarningsExact identifier
application number: M016
Akin Diaper RashZINC OXIDESouthern Sales & Service, Inc.f5515517-7977-48f9-aab6-cf0d2f2a04a02023-11-29WarningsExact identifier
application number: M016
Dr. Sheffield Diaper RashZINC OXIDESheffield Pharmaceuticals LLCcac77320-b5cf-4edf-9693-ebabfb61390c2023-11-28WarningsExact identifier
application number: M016
Sheffield Zinc OxideZINC OXIDESheffield Pharmaceuticals LLC60b54c04-4387-4954-951d-1658099473102023-11-28WarningsExact identifier
application number: M016
Cetaphil Baby Soothe and Protect CreamALLANTOINGalderma Laboratories, L.P.38254e03-3716-4e45-86b7-06430ebadc862023-11-22WarningsExact identifier
application number: M016
Cetaphil Baby Eczema SoothingCOLLOIDAL OATMEALGalderma Laboratories, L.P.d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b2023-11-22WarningsExact identifier
application number: M016
EczemaHoneyBodyLotionCOLLOIDAL OATMEALAllure Labs0a710be0-562e-8368-e063-6294a90a3b1b2023-11-18WarningsExact identifier
application number: M016
Zinc OxideSKIN PROTECTANTBluePoint Laboratoriesd9b752e6-655a-19a6-e053-2995a90a9a372023-11-17WarningsExact identifier
application number: M016
UNIVERSAL ORIGINAL PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC47b8c720-ad1e-4ac7-ba73-872e409b38bf2023-11-17WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSNac7da793-8a39-4b47-b075-a4c4820cadad18
204754petrolatum 1 MG/MG Topical OintmentSCDac7da793-8a39-4b47-b075-a4c4820cadad18
204754petrolatum 100 % Topical JellySYac7da793-8a39-4b47-b075-a4c4820cadad18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-069-2755319006927368 g in 1 JAR (55319-069-27) 368 g2009-01-050000-00-00NoNoCurrent
55319-069-9655319006996213 g in 1 JAR (55319-069-96) 213 g2009-01-050000-00-00NoNoCurrent